Sample Management in Clinical Research
Write your awesome label here.
eLearning course
Course type
4 hrs
Study time
Online
Mode of learning
4 CPD points
4 Clinical
(80% average required)
(80% average required)
Course overview
Data integrity around sample management is a team effort, meaning all site staff, CRAs, and Lab Personnel involved in sample management, must ensure that their samples are collected, processed, stored, shipped, received and analysed according to standardised principles – Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP), and processes – outlined in the Study Protocol and Lab Manuals – as well as document all these according to Good Documentation Practices and the ALCOA++ principles.
With our immersive and engaging online course in Sample Management, TASK Research Academy will take you on a unique journey, giving you the opportunity to discover, explore and develop competence in sample management and its various stages in a clinical trial, from the pre-analytical stage (preparation, collection to shipment) all the way to its post-analytical stage, as well as performing critical oversight, as conducted in-house as well as by the CRA/monitor.
Advocated by years of industry experience and developed by industry subject matter experts, this course will equip you with the knowledge and skills needed for quality sample management in a clinical trial. The course will also introduce you to all the various role players involved and what their responsibilities are toward ensuring the maintenance of sample integrity throughout its lifecycle.
Advocated by years of industry experience and developed by industry subject matter experts, this course will equip you with the knowledge and skills needed for quality sample management in a clinical trial. The course will also introduce you to all the various role players involved and what their responsibilities are toward ensuring the maintenance of sample integrity throughout its lifecycle.
The ultimate purpose of a clinical trial is to establish whether a treatment or intervention (such as a drug, vaccine, device, or procedure) is safe and effective in its purpose, for human use. The data, generated from a trial, helps regulatory authorities, healthcare providers, and researchers make evidence-based decisions about whether the intervention should be approved, how it should be used, and what its benefits and risks are.
The data is generated from collected samples of participants of the trial. Biological samples are not considered as endpoints in a clinical trial. However, these samples (such as blood, sputum, tissue, or urine) are critical to measuring endpoints, especially in trials that rely on biomarkers, pharmacokinetics (PK), or pharmacodynamics (PD) data.
If the samples are used to measure the primary endpoints, it is even more critical that they are handled correctly as failing to meet primary endpoints can make regulatory approval and scientific validation more difficult.
As such, the collection, handling, processing, storing, transporting, receipt, and analysis of biological samples is key to the integrity of the data generated in a clinical trial.
Enrol now to ensure your trial's sample integrity!
Enrol now to ensure your trial's sample integrity!
Who is this course for?
This course will benefit any role player involved in the preparation, collection, processing, storing, shipping, receiving, analysis as well as quality control oversight and verification of biological sample management in clinical trials, such as:
- Principal Investigators
- Study Coordinators
- Study Nurses
- On-site Lab Technicians, responsible for sample processing, storage and shipment on site.
- Couriers and Drivers, responsible for transporting samples.
- Clinical Research Associates (CRAs)
- Central Monitors
- Clinical Trial Managers
- Central Lab Coordinator / Lab Manager
- Laboratory Analysts / Scientists
- Quality Assurance (QA)
- Data Managers
- Biostatisticians
- Medical Monitors
- Sponsor Sample Management Lead
- Regulatory Affairs.
Required qualification
None.
The course is for research naïve individuals who want to transition into the dynamic field of clinical research, as well as healthcare professionals within the industry needing to improve their sample management competency.
Develop your professional skills
Why choose TASK Research Academy?
Among Clinical Research Academies, TASK Research Academy stands out as uniquely positioned to comprehend challenges, forge new narratives, and lead positive transformation, not only within Africa, but worldwide.
It's not only what we teach, but how we teach that sets us apart. At TASK Research Academy, we specialise in creating immersive, simulation-based learning that breaks down silos in the industry, by situating content within the context of the entire clinical trial lifecycle.
In addition, our courses are narrative-driven, have a logical flow, are easy to understand, and are full of practical tips and tools developed to help the individual with the day-to-day experiences of working in clinical trials.
Our mission presents an exceptional opportunity to shape a new global perspective on compliance and competency training, assisting in professionalising the clinical research industry.
Our goal is to be an international one-stop shop for all your clinical trial training needs, by providing a solution for individuals from being research-naïve to hitting the ground running.
About TASK Research Academy
At TASK Research Academy, we believe that learning should be fun, interactive, and immersive. That’s why our programmes are crafted by industry experts to ensure they meet the highest standards and best practices. We are dedicated to providing training that is not only high-quality and comprehensive but also flexible and accessible, catering to the needs of individuals and businesses alike.
Join us on a journey to unlock your potential and achieve professional certification through our courses. Whether you’re a newcomer looking to break into the field or a seasoned professional seeking to enhance your skills, Task Research Academy is your ultimate destination for career development in clinical research.
Step into the future of clinical research training with us and watch your career soar!
Quality Assured
Established in 2022
Trusted Provider
Task Academy contact info
Follow Task Academy on social media
Available on mobile and web
Simplest way to online learning
Download the EMGuidance app for learn on the go. Wherever, Whenever.
Write your awesome label here.
